Vial with optimized neck for improved side compression performance

ABSTRACT

A glass container is provided having a glass tube with a first end and a second end and a glass bottom closing the second end. The glass tube has a longitudinal axis and has, in a direction from the first to the second end, a top region, a junction region, a neck region, a shoulder region, and a body region. The top region is at the first end and has an outer diameter (dt), the neck region has an outer diameter (dn) with dn&lt;dt, the body region extends to the second end and has an outer diameter (db) with db&gt;dt, and the glass tube in the body region has a thickness (lb). The outer contour in a transition area between the top and neck regions is defined by a radius of curvature. The glass containers have a neck squeeze test load of at least 1100 N.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/920,793 filed Jul. 6, 2020, which claims benefit under 35 USC §119(a) of European Application 19184534.6 filed Jul. 4, 2019, the entirecontents of all of which are incorporated herein by reference.

BACKGROUND 1. Field of the Invention

The present invention relates to a glass container comprising ascontainer parts i) a glass tube with a first end and a further end,wherein the glass tube is characterized by a longitudinal axis L_(tube)and comprises, in a direction from the top to the bottom, ia) a topregion that is located at the first end of the glass tube, ib) ajunction region that follows the top region, ic) a neck region thatfollows the junction region, id) a shoulder region that follows the neckregion and ie) a body region that follows the shoulder region and thatextends to the further end of the glass tube, and ii) a glass bottomthat closes the glass tube at the further end.

Further, the invention relates to a plurality of glass containers, to aprocess for the preparation of a glass container, to a glass containerobtainable by this process, to a process for the preparation of a closedglass container, to a closed glass container obtainable by this processand to the use of a glass container for packaging a pharmaceuticalcomposition.

2. Description of Related Art

In the pharmaceutical industry, containers are used for the primarypackaging of drugs. Among the traditionally most used materials is aglass container, as it ensures stability, visibility, endurance,rigidity, moisture resistance, ease of capping, and economy. The glasscontainers for medicinal purposes currently on the market include glasscontainers, made from glass tubing and blow-molded glass containers. Themanufacturing methods for tubing-based glass containers and blow-moldedglass containers are widely known. Tubing based glass containers aremade from prefabricated glass tubing (mother tube) by shaping andseparation. In a typical manufacturing process, a glass tube is loadedinto the head of a rotary machine, and then, while rotating around itsmajor axis, one end of a glass tube is heated to the softening point ofthe glass for the formation of a top region, a neck region and ashoulder that both characterize the final form at the top of the glasscontainer. After the top region has been formed, the glass tube is againheated to its softening point at a well-defined position above the thusformed top region and is then pulled along its major axis for stretchingand spreading the portion that has been subjected to heat softening tocreate and shape the bottom of the desired container. Blow-molded glasscontainers are made by shaping a glass melt directly by blowing orpress-and-blow processes. The blow-molded glass containers include, forexample, spray and infusion bottles, such as those described in DE 19622 550 A1. However, blow-molded glass containers do typically have muchhigher tolerances in the wall thickness including local sections withhigher and lower wall thicknesses. Due to refraction of light they aretypically not suitable for optical inspection of a filled containerthrough the glass wall, what renders them unsuitable for manypharmaceutical applications.

Glass vials that are intended for pharmaceutical packaging must passnumerous mechanical tests. High axial loads that are determined in a socalled “vertical compression test” may, for example, be required ifglass vials are used in automated sampling machines in scientific labsor medical institutions as well as during stoppering, shipping, andstorage of glass vials. In addition to a certain resistance to axialloads glass containers should also display sufficiently high burststrength as determined in the so-called “burst pressure test”. Burstpressure testing is, for example, appropriate if pharmaceuticalpreparations, after they have been filled in a glass container, aresubjected to lyophilisation in order to find the weakest point on theinterior or exterior surface of a container.

A further mechanical test that is often used to determine the mechanicalstrength of a glass vial is the so called “side compression test”. Thistest is used, for example, to determine the impact that a certain backpressure may have on the glass vials during transport in adepyrogenation tunnel or generally during transport on a filling line.In this test the glass vials are positioned between an upper and a lowerportion of a test tool as shown in FIG. 1 , wherein a defined load isapplied directly onto the body region of the glass vial.

As the use of glass vials in pharmaceutical industry only allows a verylow failure probability upon application of mechanical stress, glassvials intended for the filling of pharmaceutical preparations shouldtherefore be characterized by sufficiently high strength, particularlyby a sufficiently high ability to withstand a certain pressure in theabove described side compression test. Although ISO-vials are alreadyadapted to these increased stability requirements, the strength of glassvials can be further improved. For example, to increase the strength ofglass containers the glass surface of the containers can be hardened,for example by means of chemical treatments as disclosed in WO1981/002572 A1 or in EP 0 495 936 A1. However, such a hardening processrequires an additional process step in the manufacturing of glasscontainers and—in case of chemical treatments—also leads to amodification of the glass surface. Therefore, a chemically strengthenedglass surface typically requires a new approval of the glass container.

SUMMARY

In general, it is an object of the present invention to at least partlyovercome a disadvantage arising from the prior art. It is a furtherobject of the invention to provide a glass container, preferably a glassvial, for pharmaceutical packaging which has an improved strength in aside compression test in which a certain load is directly applied ontothe body portion of the glass container, particularly compared to theISO-vials known from the prior art. It is a further object of theinvention to provide a glass container, preferably a glass vial, forpharmaceutical packaging which has an improved strength in a sidecompression test in which a certain load is directly applied onto thebody portion of the glass container, particularly compared to theISO-vials known from the prior art, and which has been prepared by aprocess as simple as possible, preferably from prefabricated glass tubesby shaping and separation. It is a further object of the invention toprovide a process for the preparation of a glass container, preferably aglass vial, for pharmaceutical packaging which has an improved strengthin a side compression test in which a certain load is directly appliedonto the body portion of the glass container, particularly compared tothe ISO-vials known from the prior art, from prefabricated glass tubesby shaping and separation, wherein no additional process steps such as amodification of the glass surface is required.

A contribution to at least partly solving at least one, preferably morethan one, of the above objects is made by the embodiments disclosedherein.

A contribution to solving at least one of the objects according to theinvention is made by an embodiment 1 of a glass container 1 comprisingas container parts

a glass tube with a first end and a further end, wherein the glass tubeis characterized by a longitudinal axis L_(tube) and comprises, in adirection from the top to the bottom: ia) a top region that is locatedat the first end of the glass tube, wherein the outer diameter of thetop region is d_(t); ib) a junction region that follows the top region;ic) a neck region that follows the junction region, wherein the outerdiameter of the neck region is d_(n) with d_(n)<d_(t); id) a shoulderregion that follows the neck region; and ie) a body region that followsthe shoulder region and that extends to the further end of the glasstube, wherein the thickness of the glass in the body region is l_(b) andwherein the outer diameter of the body region is d_(b) with d_(b)>d_(t);ii) a glass bottom that closes the glass tube at the further end;wherein, if the glass container is placed on a plane horizontalsubstrate with the outer surface of the body region on it, within anygiven cross-section of the glass container that is located in a planebeing centrically located in the glass container and comprising thelongitudinal axis L_(tube) of the glass tube, f(x) defines the verticaldistance between the substrate and the outer surface of the glasscontainer at a given position x and l(x) defines the thickness of theglass at a given position x, wherein the thickness of the glass l(x) ismeasured in a direction perpendicular to longitudinal axis L_(tube);wherein k(x)=|f″(x)/[1+f′(x)²]^(3/2)| defines the absolute value of thecurvature of f(x) at a given position x; and wherein in the intervalbetween x=P₁ and x=P₂ for any concave curvature in this interval theminimum value for [l(x)/l_(b)]³/k(x) is at least 0.35 mm, preferably atleast 0.5 mm, more preferably at least 0.7 mm, even more preferably atleast 0.9 mm, even more preferably at least 1.1 mm, even more preferablyat least 1.3 mm, even more preferably at least 1.5 mm, even morepreferably at least 1.7 mm, even more preferably at least 2.0 mm andmost preferably at least 2.5 mm, wherein P₂ defines the x-position atwhich f(x) is ½×d_(b)−¼×d_(t)−¼×d_(n) and P₁ is P₂−d_(t)/2+d_(n)/2.

A contribution to solving at least one of the objects according to theinvention is also made by an embodiment 1 of a plurality 1 of glasscontainers, each glass container comprising as container parts a glasstube with a first end and a further end, wherein the glass tube ischaracterized by a longitudinal axis L_(tube) and comprises, in adirection from the top to the bottom: ia) a top region that is locatedat the first end of the glass tube, wherein the outer diameter of thetop region is d_(t); ib) a junction region that follows the top region;ic) a neck region that follows the junction region, wherein the outerdiameter of the neck region is d_(n) with d_(n)<d_(t); id) a shoulderregion that follows the neck region; and ie) a body region that followsthe shoulder region and that extends to the further end of the glasstube, wherein the thickness of the glass in the body region is l_(b) andwherein the outer diameter of the body region is d_(b) with d_(b)>d_(t);a glass bottom that closes the glass tube at the further end; whereinthe load under which 50% of the glass containers (100) contained in theplurality of glass containers (100) break in the neck squeeze test asdescribed herein is at least 1100 N, preferably at least 1200 N, morepreferably at least 1300 N, even more preferably at least 1400 N, evenmore preferably at least 1500 N, even more preferably at least 1600 N,even more preferably at least 1800 N, even more preferably at least 2000N, even more preferably at least 2500 N and most preferably at least3000 N.

In an embodiment 2 of a plurality 1 of glass containers the plurality 1is designed according to its embodiment 1, wherein for at least 75%,preferably for at least 85%, more preferably for at least 95% and mostpreferably for each of the glass containers contained in the plurality 1of glass containers the following conditions are fulfilled: if the glasscontainer is placed on a plane horizontal substrate with the outersurface of the body region on it, within any given cross-section of theglass container that is located in a plane being centrically located inthe glass container and comprising the longitudinal axis L_(tube) of theglass tube, f(x) defines the vertical distance between the substrate andthe outer surface of the glass container at a given position x and l(x)defines the thickness of the glass at a given position x, wherein thethickness of the glass l(x) is measured in a direction perpendicular tolongitudinal axis L_(tube); k(x)=|f″(x)/[1+f′(x)²]^(3/2)| defines theabsolute value of the curvature of f(x) at a given position x; and inthe interval between x=P₁ and x=P₂ for any concave curvature in thisinterval the minimum value for [l(x)/l_(b)]³/k(x) is at least 0.35 mm,preferably at least 0.5 mm, more preferably at least 0.7 mm, even morepreferably at least 0.9 mm, even more preferably at least 1.1 mm, evenmore preferably at least 1.3 mm, even more preferably at least 1.5 mm,even more preferably at least 1.7 mm, even more preferably at least 2.0mm and most preferably at least 2.5 mm, wherein P₂ defines thex-position at which f(x) is ½×d_(b)−¼×d_(t)−¼×d_(n) and P₁ isP₂−d_(t)/2+d_(n)/2.

“A plurality of glass containers” in the sense of the present inventionpreferably comprises at least 10 glass containers, preferably at least25 glass containers, more preferably at least 50 glass containers, evenmore preferably at least 75 glass containers and most preferably atleast 100 glass containers. Furthermore, the plurality of glasscontainers preferably has been collected arbitrarily and particularlyhas not been selected with regard to any property. For example, theplurality of glass containers may be the group of containers which arepacked together in a typical transport tray.

Surprisingly, it has been observed that the mechanical strength of aglass container in a side compression test known from the prior art, i.e. in a static load test in which a load is directly applied only ontothe body region of the glass container, can be significantly improved bycontrolling the local curvature of the outer contour of the glasscontainer in the area that comprises the junction region and the neckregion, i. e. in an area which—as shown in FIG. 1 —in the sidecompression test known from the prior art is not in contact with theupper and the lower portion of a test tool that is used to apply thedesired load. It also has been observed that glass containers which passthe neck side compression test as described herein are alsocharacterized by an improved mechanical strength in the side compressiontest known from the prior art. This is again surprising as in the sidecompression test known from the prior art a load is directly appliedonly onto the body region of the glass container, but not to the neckregion. A person skilled in the art could therefore not expect that animprovement of the mechanical strength in the neck region towardslaterally applied loads will also improve the mechanical strength withregards to loads in the body region.

In an embodiment 2 of the glass container 1 according to the inventionor in an embodiment 3 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 1 or the plurality 1 of glass containers is designedaccording to its embodiment 1 or 2, ib) wherein the junction region hasan outer surface that at the end at which the junction region mergesinto the neck region is substantially circular arc-shaped, thesubstantially circular arc-shaped area having an outer radius r_(s); ic)wherein the minimum thickness of the glass in the neck region (106) isl_(n); and wherein for the glass container 1 or for at least 75%,preferably for at least 85%, more preferably for at least 95% and mostpreferably for each glass container contained in the plurality 1 ofglass containers the following condition is fulfilled:2×[l_(n)/l_(b)]×r_(s)≥0.9 mm; preferably 2×[l_(n)/l_(b)]×r_(s)≥1.0 mm;more preferably 2×[l_(n)/l_(b)]×r_(s)≥1.1 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥1.2 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥1.3 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥1.4 mm; even most preferably2×[l_(n)/l_(b)]×r_(s)≥1.5 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥1.7 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥2.0 mm; most preferably 2×[l_(n)/l_(b)]×r_(s)≥2.5mm.

In an embodiment 3 of the glass container 1 according to the inventionor in an embodiment 4 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 1 or 2 or the plurality 1 of glass containers is designedaccording to anyone of its embodiments 1 to 3, wherein the minimumthickness of the glass in the neck region is l_(n) and wherein for theglass container 1 or for at least 75%, preferably for at least 85%, morepreferably for at least 95% and most preferably for each glass containercontained in the plurality 1 of glass containers the following conditionis fulfilled: l_(n)/l_(b)≥1.3 preferably l_(n)/l_(b)≥1.4; morepreferably l_(n)/l_(b)≥1.45; even more preferably l_(n)/l_(b)≥1.5; mostpreferably l_(n)/l_(b)≥1.6.

In an embodiment 4 of the glass container 1 according to the inventionor in an embodiment 5 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 3 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 4, wherein for theglass container 1 or for at least 75%, preferably for at least 85%, morepreferably for at least 95% and most preferably for each glass containercontained in the plurality 1 of glass containers d_(t) is in the rangefrom 12 to 14 mm, preferably in the range from 12.5 to 13.5 mm and morepreferably in the range from 12.7 to 13.2 mm or d_(t) is in the rangefrom 19 to 21 mm, preferably in the range from 19.5 to 20.5 mm and morepreferably in the range from 19.7 to 20.2 mm.

In an embodiment 5 of the glass container 1 according to the inventionor in an embodiment 6 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 4 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 5, wherein for theglass container 1 or for at least 75%, preferably for at least 85%, morepreferably for at least 95% and most preferably for each glass containercontained in the plurality 1 of glass containers one of the followingconditions are fulfilled: the filling volume is in the range from 1 mlto 8 ml and d_(n) is in the range from 9 to 12 mm, preferably in therange from 9.5 to 10.5 mm, more preferably in the range from 9.7 to 10.3mm, even more preferably in the range from 9.8 to 10.3 mm and mostpreferably in the range from 9.9 to 10.3 mm; the filling volume is inthe range from 8.5 ml to 22 ml and d_(n) is in the range from 14.5 to 18mm, preferably in the range from 15.2 to 16.5 mm, more preferably in therange from 15.5 to 16.3 mm, even more preferably in the range from 15.7to 16.3 mm and most preferably in the range from 15.9 to 16.3 mm; or thefilling volume is in the range from 22.5 ml to 150 ml and d_(n) is inthe range from 15.0 to 20 mm, preferably in the range from 16.0 to 17.5mm, more preferably in the range from 16.5 to 17.3 mm, even morepreferably in the range from 16.7 to 17.3 mm and most preferably in therange from 16.9 to 17.3 mm.

In an embodiment 6 of the glass container 1 according to the inventionor in an embodiment 7 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 5 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 6, wherein for theglass container 1 or for at least 75%, preferably for at least 85%, morepreferably for at least 95% and most preferably for each glass containercontained in the plurality 1 of glass containers d_(b) is in the rangefrom 14 to 60 mm, preferably in the range from 15 to 32 mm, morepreferably in the range from 15 to 25 mm, even more preferably in therange from 15 to 23 mm and most preferably in the range from 15 to 17mm.

In an embodiment 7 of the glass container 1 according to the inventionor in an embodiment 8 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 6 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 7, wherein for theglass container 1 or for at least 75%, preferably for at least 85%, morepreferably for at least 95% and most preferably for each glass containercontained in the plurality 1 of glass containers d_(t)−d_(n) is in therange from 1.5 to 6 mm, preferably in the range from 2 to 5 mm, morepreferably in the range from 2.5 to 4.5 mm, even more preferably in therange from 2.5 to 4 mm and most preferably in the range from 2.5 to 3.5mm.

In an embodiment 8 of the glass container 1 according to the inventionor in an embodiment 9 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 7 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 8, wherein for theglass container 1 or for at least 75%, preferably for at least 85%, morepreferably for at least 95% and most preferably for each glass containercontained in the plurality 1 of glass containers d_(b)−d_(n) is in therange from 4 to 35 mm, preferably in the range from 4 to 15 mm, morepreferably in the range from 5 to 13 mm, even more preferably in therange from 5 to 8 mm and most preferably in the range from 5 to 6 mm.

In an embodiment 9 of the glass container 1 according to the inventionor in an embodiment 10 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 8 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 9, wherein theshoulder in the shoulder region is characterized by a shoulder angle αand wherein for the glass container 1 or for at least 75%, preferablyfor at least 85%, more preferably for at least 95% and most preferablyfor each glass container contained in the plurality 1 of glasscontainers α is in the range from 10 to 70°, preferably in the rangefrom 25 to 60°, more preferably in the range from 33 to 55°, even morepreferably in the range from 37 to 50° and most preferably in the rangefrom 38° to 45°.

In an embodiment 10 of the glass container 1 according to the inventionor in an embodiment 11 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 9 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 10, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers the container part fromthe glass bottom up to the top region is rotation-symmetric around thelongitudinal axis that goes perpendicular through the centre of theglass bottom.

In an embodiment 11 of the glass container 1 according to the inventionor in an embodiment 12 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 10 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 11, wherein for theglass container 1 or for at least 75%, preferably for at least 85%, morepreferably for at least 95% and most preferably for each glass containercontained in the plurality 1 of glass containers throughout the bodyregion the wall thickness n_(b) of the glass tube is in a range from±0.2 mm, preferably ±0.1 mm, more preferably ±0.08 mm and mostpreferably ±0.05 mm, in each case based on a mean value of this wallthickness in the body region.

In an embodiment 12 of the glass container 1 according to the inventionor in an embodiment 13 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 11 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 12, wherein theglass container has a mass of glass mg and an interior volume V_(i) andwherein for the glass container 1 or for at least 75%, preferably for atleast 85%, more preferably for at least 95% and most preferably for eachglass container contained in the plurality 1 of glass containers thefollowing condition is fulfilled: m_(g)/V_(i) ^(0.75)<2.0; preferablym_(g)/V_(i) ^(0.75)<1.75.

In an embodiment 13 of the glass container 1 according to the inventionor in an embodiment 14 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 12 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 13, wherein theglass container has an interior volume V_(i) and wherein for the glasscontainer 1 or for at least 75%, preferably for at least 85%, morepreferably for at least 95% and most preferably for each glass containercontained in the plurality 1 of glass containers V_(i) in a range from 2to 150 ml, preferably from 3 to 100 ml, more preferably from 3 to 50 ml,even more preferably from 3 to 15 ml, most preferably from 3 to 7 ml.

In an embodiment 14 of the glass container 1 according to the inventionor in an embodiment 15 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 13 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 14, wherein theglass container has a height h_(c) and wherein for the glass container 1or for at least 75%, preferably for at least 85%, more preferably for atleast 95% and most preferably for each glass container contained in theplurality 1 of glass containers h_(c) in the range from 15 to 100 mm,preferably in the range from 20 to 60 mm, more preferably in the rangefrom 25 to 55 mm, even more preferably in the range from 30 to 50 mm andmost preferably in the range from 34 to 46 mm.

In an embodiment 15 of the glass container 1 according to the inventionor in an embodiment 16 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 14 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 15, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers is/are a packagingcontainer for a medical or a pharmaceutical packaging good or both. Apreferred pharmaceutical packaging good is a pharmaceutical composition.Preferably, the glass container 1 or the glass containers contained inthe plurality 1 of glass containers is/are suitable for packagingparenteralia in accordance with section 3.2.1 of the EuropeanPharmacopoeia, 7th edition from 2011.

In an embodiment 16 of the glass container 1 according to the inventionor in an embodiment 17 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 15 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 16, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers is/are a vial.

In an embodiment 17 of the glass container 1 according to the inventionor in an embodiment 18 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 2 to 16 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 3 to 17, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers is/are a vial with aninterior volume of 1 to 8 ml and wherein the following conditions arefulfilled: d_(n)≥9.5 mm; r_(s)≥0.5 mm.

In an embodiment 18 of the glass container 1 according to the inventionor in an embodiment 19 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 17 or the plurality 1 of glass containers is designedaccording to its embodiment 18, wherein for the glass container 1 or forat least 75%, preferably for at least 85%, more preferably for at least95% and most preferably for each glass container contained in theplurality 1 of glass containers the following condition is fulfilled:d_(n)≥9.5 mm; preferably d_(n)≥9.6 mm; more preferably d_(n)≥9.7 mm;even more preferably d_(n)≥9.8 mm; most preferably d_(n)≥9.9 mm.

In an embodiment 19 of the glass container 1 according to the inventionor in an embodiment 20 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiments 17 or 18 or the plurality 1 of glass containers is designedaccording to its embodiments 18 or 19, wherein for the glass container 1or for at least 75%, preferably for at least 85%, more preferably for atleast 95% and most preferably for each glass container contained in theplurality 1 of glass containers the following condition is fulfilled:r_(s)≥0.5 mm; preferably r_(s)≥0.55 mm; more preferably r_(s)≥0.6 mm;even more preferably r_(s)≥0.7 mm; most preferably r_(s)≥0.8 mm.

In an embodiment 20 of the glass container 1 according to the inventionor in an embodiment 21 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 17 to 19 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 18 to 20, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers is/are a vial with asize designation “2R” or “4R” according to DIN EN ISO 8362-1:2016-06.

In an embodiment 21 of the glass container 1 according to the inventionor in an embodiment 22 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 2 to 16 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 3 to 17, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers is/are a vial with aninterior volume of 8.5 to 22 ml and wherein the following conditions arefulfilled: d_(n)≥15.5 mm; r_(s)≥0.5 mm.

In an embodiment 22 of the glass container 1 according to the inventionor in an embodiment 23 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 21 or the plurality 1 of glass containers is designedaccording to its embodiment 22, wherein for the glass container 1 or forat least 75%, preferably for at least 85%, more preferably for at least95% and most preferably for each glass container contained in theplurality 1 of glass containers the following condition is fulfilled:d_(n)≥15.5 mm; preferably d_(n)≥15.6 mm; more preferably d_(n)≥15.7 mm;even more preferably d_(n)≥15.8 mm; most preferably d_(n)≥15.9 mm.

In an embodiment 23 of the glass container 1 according to the inventionor in an embodiment 24 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiments 21 or 22 or the plurality 1 of glass containers is designedaccording to its embodiments 22 or 23, wherein for the glass container 1or for at least 75%, preferably for at least 85%, more preferably for atleast 95% and most preferably for each glass container contained in theplurality 1 of glass containers the following condition is fulfilled:r_(s)≥0.5 mm; preferably r_(s)≥0.55 mm; more preferably r_(s)≥0.6 mm;even more preferably r_(s)≥0.7 mm; most preferably r_(s)≥0.8 mm.

In an embodiment 24 of the glass container 1 according to the inventionor in an embodiment 25 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 21 to 23 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 22 to 24, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers is/are a vial with asize designation “6R”, “8R” or “10R” according to DIN EN ISO8362-1:2016-06.

In an embodiment 25 of the glass container 1 according to the inventionor in an embodiment 26 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 2 to 16 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 3 to 17, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers is/are a vial with aninterior volume of 22.5 to 150 ml and wherein the following conditionsare fulfilled: d_(n)≥16.5 mm; r_(s)≥0.5 mm.

In an embodiment 26 of the glass container 1 according to the inventionor in an embodiment 27 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 25 or the plurality 1 of glass containers is designedaccording to its embodiment 26, wherein for the glass container 1 or forat least 75%, preferably for at least 85%, more preferably for at least95% and most preferably for each glass container contained in theplurality 1 of glass containers the following condition is fulfilled:d_(n)≥16.5 mm; preferably d_(n)≥16.6 mm; more preferably d_(n)≥16.7 mm;even more preferably d_(n)≥16.8 mm; most preferably d_(n)≥16.9 mm.

In an embodiment 27 of the glass container 1 according to the inventionor in an embodiment 28 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiments 25 or 26 or the plurality 1 of glass containers is designedaccording to its embodiments 26 or 27, wherein for the glass container 1or for at least 75%, preferably for at least 85%, more preferably for atleast 95% and most preferably for each glass container contained in theplurality 1 of glass containers the following condition is fulfilled:r_(s)≥0.5 mm; preferably r_(s)≥0.55 mm; more preferably r_(s)≥0.6 mm;even more preferably r_(s)≥0.7 mm; most preferably r_(s)≥0.8 mm.

In an embodiment 28 of the glass container 1 according to the inventionor in an embodiment 29 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 25 to 27 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 26 to 28, wherein theglass container 1 or at least 75%, preferably at least 85%, morepreferably at least 95% and most preferably each glass containercontained in the plurality 1 of glass containers is/are a vial with asize designation “20R, “25R”, “30R”, “50R” or “100R” according to DIN ENISO 8362-1:2016-06.

In an embodiment 29 of the glass container 1 according to the inventionor in an embodiment 30 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 28 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 29, wherein theglass is of a type selected from the group consisting of a borosilicateglass, an aluminosilicate glass, soda lime glass and fused silica. “Sodalime glass” according to the invention is an alkaline/alkalineearth/silicate glass according to TABLE 1 of ISO 12775 (1^(st) edition1997 Oct. 15).

In an embodiment 30 of the glass container 1 according to the inventionor in an embodiment 31 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiments 1 to 29 or the plurality 1 of glass containers isdesigned according to anyone of its embodiments 1 to 30, wherein theglass container comprises a coating that at least partially superimposesthe exterior surface, the interior surface or the exterior and theinterior surface of the glass tube.

In an embodiment 31 of the glass container 1 according to the inventionor in an embodiment 32 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 30 or the plurality 1 of glass containers is designedaccording to its embodiment 31, wherein the coating comprises asilicone, a silane or a mixture thereof, wherein the silicone or thesilane can be crosslinked or non-crosslinked. Suitable silanes andsilicones for treating the surface of glass containers are, forexamples, disclosed in US 2011/0006028 A1, U.S. Pat. No. 4,420,578 or inWO 2014/105350 A3.

In an embodiment 32 of the glass container 1 according to the inventionor in an embodiment 33 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 30 or the plurality 1 of glass containers is designedaccording to its embodiment 31, wherein the coating preferably comprisesa coupling agent layer positioned on the exterior surface (i. e. thesurface opposite to the interior surface that directed to the interiorvolume V_(i) of the glass container) of the glass tube, the couplingagent layer comprising a coupling agent; and a polymer layer positionedover the coupling agent layer, the polymer layer comprising a polymerchemical composition. Preferably, the coating is a coating as describedin US 2013/171456 A1.

In an embodiment 33 of the glass container 1 according to the inventionor in an embodiment 34 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 32 or the plurality 1 of glass containers is designedaccording to its embodiment 33, wherein the coating further comprises aninterface layer positioned between the coupling agent layer and thepolymer layer; and the interface layer comprises one or more chemicalcompositions of the polymer layer bound with one or more of the chemicalcompositions of the coupling agent layer.

In an embodiment 34 of the glass container 1 according to the inventionor in an embodiment 35 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 32 or 33 or the plurality 1 of glass containers is designedaccording to its embodiment 33 or 34, wherein the coupling agentcomprises at least one of: a first silane chemical composition, ahydrolysate thereof, or an oligomer thereof; and a chemical compositionformed from the oligomerization of at least the first silane chemicalcomposition and a second silane chemical composition, wherein the firstsilane chemical composition and the second silane chemical compositionare different chemical compositions.

In an embodiment 35 of the glass container 1 according to the inventionor in an embodiment 36 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 34 or the plurality 1 of glass containers is designedaccording to its embodiment 35, wherein the first silane chemicalcomposition is an aromatic silane chemical composition.

In an embodiment 36 of the glass container 1 according to the inventionor in an embodiment 37 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 32 or the plurality 1 of glass containers is designedaccording to its embodiment 33, wherein the coupling agent comprises asilsesquioxane chemical composition comprising an aromatic moiety and anamine moiety.

In an embodiment 37 of the glass container 1 according to the inventionor in an embodiment 38 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 32 or the plurality 1 of glass containers is designedaccording to its embodiment 33, wherein the coupling agent comprises atleast one of: a mixture of a first silane chemical composition and asecond silane chemical composition; and a chemical composition formedfrom the oligomerization of at least the first silane chemicalcomposition and the second silane chemical composition, wherein thefirst silane chemical composition and the second silane chemicalcomposition are different chemical compositions.

In an embodiment 38 of the glass container 1 according to the inventionor in an embodiment 39 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to itsembodiment 37 or the plurality 1 of glass containers is designedaccording to its embodiment 38, wherein the first silane chemicalcomposition is an aromatic silane chemical composition.

In an embodiment 39 of the glass container 1 according to the inventionor in an embodiment 40 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 32 to 39 or the plurality 1 of glass containers isdesigned according to anyone of its embodiment 33 to 39, wherein thepolymer chemical composition is a polyimide chemical composition.

In an embodiment 40 of the glass container 1 according to the inventionor in an embodiment 41 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 1 to 39 or the plurality 1 of glass containers isdesigned according to anyone of its embodiment 1 to 40, wherein theinterior volume V_(i) of the glass container comprises a pharmaceuticalcomposition.

In an embodiment 41 of the glass container 1 according to the inventionor in an embodiment 42 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 1 to 40 or the plurality 1 of glass containers isdesigned according to anyone of its embodiment 1 to 41, wherein theglass container 1 comprises a closure at the top of the glass container1, preferably a lid.

In an embodiment 42 of the glass container 1 according to the inventionor in an embodiment 43 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 1 to 41 or the plurality 1 of glass containers isdesigned according to anyone of its embodiment 1 to 42, wherein theglass container 1 has not been thermally tempered.

In an embodiment 43 of the glass container 1 according to the inventionor in an embodiment 44 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 1 to 42 or the plurality 1 of glass containers isdesigned according to anyone of its embodiment 1 to 43, wherein theglass of glass container 1 at least in the neck region is characterizedby a substantially homogeneous distribution of sodium across thethickness n_(b) of the glass.

In an embodiment 44 of the glass container 1 according to the inventionor in an embodiment 45 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 1 to 43 or the plurality 1 of glass containers isdesigned according to anyone of its embodiment 1 to 44, wherein theglass of glass container 1 at least in the neck region is characterizedby a substantially homogeneous distribution of potassium across thethickness n_(b) of the glass.

In an embodiment 45 of the glass container 1 according to the inventionor in an embodiment 46 of the plurality 1 of glass containers accordingto the invention, the glass container 1 is designed according to anyoneof its embodiment 1 to 44 or the plurality 1 of glass containers isdesigned according to anyone of its embodiment 1 to 45, wherein theglass of glass container 1 at least in the neck region is characterizedby a compressive stress (CS) in the outer surface region in the neckregion which is lower than 500 MPa, preferably lower than 300 MPa, evenmore preferably lower than 170 MPa, even more preferably lower than 80MPa, even more preferably lower than 30 MPa and most preferably lowerthan 15 MPa. The compressive stress can, for example, be measured with apolarimeter which is appropriate for vial geometries.

A contribution to solving at least one of the objects according to theinvention is made by an embodiment 1 of a process 1 or making an item,preferably a glass container, more preferably a glass container 1according to the invention or a glass container contained in theplurality 1 of glass containers according to the invention, comprisingas process steps: providing a glass tube with a first end and a furtherend, wherein the glass tube is characterized by a longitudinal axisL_(tube), an outer diameter d_(b) and a glass thickness n_(b); heatingthe first end of the glass tube, while rotating around its major axis,to a temperature above its glass transition temperature, preferablyabove its softening temperature, with a heating element, preferably witha flame; while the heated glass tube is rotating around its major axis,shaping the outer contour of the first end so as to obtain ia) a topregion that is located at the first end of the glass tube, wherein theouter diameter of the top region is d_(t) with d_(t)<d_(b); ib) ajunction region that follows the top region; ic) a neck region thatfollows the junction region, wherein the outer diameter of the topregion is d_(n) with d_(n)<d_(t); and id) a shoulder region that followsthe neck region; wherein shaping in process step III) is performed insuch a way that an outer counter c_(outer) of the glass tube at thefirst end is obtained that is characterized by the following feature: ifthe glass container is placed on a plane horizontal substrate with theouter surface of the body region on it, within any given cross-sectionof the glass container that is located in a plane being centricallylocated in the glass container and comprising the longitudinal axisL_(tube) of the glass tube, f(x) defines the vertical distance betweenthe substrate and the outer surface of the glass container at a givenposition x and l(x) defines the thickness of the glass at a givenposition x, wherein the thickness of the glass l(x) is measured in adirection perpendicular to longitudinal axis L_(tube); whereink(x)=|f″(x)/[1+f′(x)²]^(3/2)| defines the absolute value of thecurvature of f(x) at a given position x; and wherein in the intervalbetween x=P₁ and x=P₂ for any concave curvature in this interval theminimum value for [l(x)/l_(b)]³/k(x) is at least 0.35 mm, preferably atleast 0.5 mm, more preferably at least 0.7 mm, even more preferably atleast 0.9 mm, even more preferably at least 1.1 mm, even more preferablyat least 1.3 mm, even more preferably at least 1.5 mm, even morepreferably at least 1.7 mm, even more preferably at least 2.0 mm andmost preferably at least 2.5 mm, wherein P₂ defines the x-position atwhich f(x) is ½×d_(b)−¼×d_(t)−¼×d_(n) and P₁ is P₂−d_(t)/2+d_(n)/2.

The “softening temperature” of the glass is the temperature at which theglass has a viscosity (determined according to ISO 7884-6:1987) of10^(7.6) dPa×sec.

In an embodiment 2 of the process 1 according to the invention, theprocess 1 is designed according to its embodiment 1, wherein the processcomprises the further process steps: heating the glass tube, whilerotating around its major axis, at a defined position located above thefirst end that has been shaped in process step III) to a temperatureabove its glass transition temperature, preferably above its softeningtemperature, with a heating element, preferably with a flame; pullingthe heated glass tube, while rotating around its major axis, forstretching and creating a container closure; while the heated glass tubeis rotating around its major axis, shaping a container closure,preferably while having a temperature above its glass transitiontemperature, preferably above its softening temperature, so as to obtaina body region that follows the shoulder region and a glass bottom.

In an embodiment 3 of the process 1 according to the invention, theprocess 1 is designed according to its embodiment 1 or 2, wherein inprocess step III) shaping the outer contour c_(outer) of the junctionregion and the neck region is performed by using one or more moldingtools, preferably by using one or more molding rollers, that acts/act onpredetermined positions of the outer surface of the heated junctionregion and the heated neck region.

In an embodiment 4 of the process 1 according to the invention, theprocess 1 is designated according to anyone of its embodiments 1 to 3,wherein shaping in process step III) is performed in such a way that ib)the junction region has an outer surface that at the end at which thejunction region merges into the neck region is substantially circulararc-shaped, the substantially circular arc-shaped area having an outerradius r_(s); ic) the minimum thickness of the glass in the neck regionis l_(n); wherein the following condition is fulfilled:2×[l_(n)/l_(b)]×r_(s)≥0.9 mm; preferably 2×[l_(n)/l_(b)]×r_(s)≥1.0 mm;more preferably 2×[l_(n)/l_(b)]×r_(s)≥1.1 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥1.2 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥1.3 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥1.4 mm; even most preferably2×[l_(n)/l_(b)]×r_(s)≥1.5 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥1.7 mm; even more preferably2×[l_(n)/l_(b)]×r_(s)≥2.0 mm; most preferably 2×[l_(n)/l_(b)]×r_(s)≥2.5mm.

In an embodiment 5 of the process 1 according to the invention theprocess 1 is designed according to anyone of its embodiments 1 to 4,wherein shaping in process step III) is performed in such a way that,when the minimum thickness of the glass in the neck region is l_(n), thefollowing condition is fulfilled: l_(n)/l_(b)≥1.3; preferablyl_(n)/l_(b)≥1.4; more preferably l_(n)/l_(b)≥1.45; even more preferablyl_(n)/l_(b)≥1.5; most preferably l_(n)/l_(b)≥1.6.

In an embodiment 6 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 1 to 5,wherein shaping in process step III) is performed in such a way thatd_(t) is in the range from 12 to 14 mm, preferably in the range from12.5 to 13.5 mm and more preferably in the range from 12.7 to 13.2 mm ord_(t) is in the range from 19 to 21 mm, preferably in the range from19.5 to 20.5 mm and more preferably in the range from 19.7 to 20.2 mm.

In an embodiment 7 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 1 to 6,wherein shaping in process step III) is performed in such a way that ifthe filling volume is in the range from 1 ml to 8 ml, d_(n) is in therange from 9 to 12 mm, preferably in the range from 9.5 to 10.5 mm, morepreferably in the range from 9.7 to 10.3 mm, even more preferably in therange from 9.8 to 10.3 mm and most preferably in the range from 9.9 to10.3 mm; if the filling volume is in the range from 8.5 ml to 22 ml,d_(n) is in the range from 14.5 to 18 mm, preferably in the range from15.2 to 16.5 mm, more preferably in the range from 15.5 to 16.3 mm, evenmore preferably in the range from 15.7 to 16.3 mm and most preferably inthe range from 15.9 to 16.3 mm; or if filling volume is in the rangefrom 22.5 ml to 150 ml, d_(n) is in the range from 15.0 to 20 mm,preferably in the range from 16.0 to 17.5 mm, more preferably in therange from 16.5 to 17.3 mm, even more preferably in the range from 16.7to 17.3 mm and most preferably in the range from 16.9 to 17.3 mm.

In an embodiment 8 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 1 to 7,wherein shaping in process step III) is performed in such a way thatd_(b) is in the range from 14 to 60 mm, preferably in the range from 15to 32 mm, more preferably in the range from 15 to 25 mm, even morepreferably in the range from 15 to 23 mm and most preferably in therange from 15 to 17 mm.

In an embodiment 9 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 1 to 8,wherein shaping in process step III) is performed in such a way thatd_(t)−d_(n) is in the range from 1.5 to 6 mm, preferably in the rangefrom 2 to 5 mm, more preferably in the range from 2.5 to 4.5 mm, evenmore preferably in the range from 2.5 to 4 mm and most preferably in therange from 2.5 to 3.5 mm.

In an embodiment 10 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 1 to 9,wherein shaping in process step III) is performed in such a way thatd_(b)−d_(n) is in the range from 4 to 35 mm, preferably in the rangefrom 4 to 15 mm, more preferably in the range from 5 to 13 mm, even morepreferably in the range from 5 to 8 mm and most preferably in the rangefrom 5 to 6 mm.

In an embodiment 11 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 1 to 10,wherein shaping in process step III) is performed in such a way that theshoulder in the shoulder region is characterized by a shoulder angle αand wherein α is in the range from 10 to 70°, preferably in the rangefrom 25 to 60°, more preferably in the range from 33 to 55°, even morepreferably in the range from 37 to 50° and most preferably in the rangefrom 38° to 45°.

In an embodiment 12 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 1 to 11,wherein shaping in process step III) is performed in such a way that theglass container in the container part from the glass bottom up to thetop region is rotation-symmetric around the longitudinal axis that goesperpendicular through the centre of the glass tube.

In an embodiment 13 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiment 1 to 12,wherein the wall thickness n_(b) of the glass tube is in a range from±0.2 mm, preferably ±0.1 mm, more preferably ±0.08 mm and mostpreferably ±0.05 mm, in each case based on a mean value of this wallthickness in the glass tube.

In an embodiment 14 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 4 to 13,wherein the glass container is a vial with an interior volume of 1 to 8ml and wherein shaping in process step III) is performed in such a waythat the following conditions are fulfilled: d_(n)≥9.5 mm; r_(s)≥0.5 mm.

In an embodiment 15 of the process 1 according to the invention theprocess 1 is designed according to its embodiment 14, wherein shaping inprocess step III) is performed in such a way that the followingconditions are fulfilled: d_(n)≥9.5 mm; preferably d_(n)≥9.6 mm; morepreferably d_(n)≥9.7 mm; even more preferably d_(n)≥9.8 mm; mostpreferably d_(n)≥9.9 mm.

In an embodiment 16 of the process 1 according to the invention theprocess 1 is designed according to its embodiment 14 or 15, whereinshaping in process step III) is performed in such a way that thefollowing conditions are fulfilled: r_(s)≥0.5 mm; preferably r_(s)≥0.55mm; more preferably r_(s)≥0.6 mm; even more preferably r_(s)≥0.7 mm;most preferably r_(s)≥0.8 mm.

In an embodiment 17 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 4 to 13,wherein the glass container is a vial with an interior volume of 8.5 to22 ml and wherein shaping in process step III) is performed in such away that the following conditions are fulfilled: d_(n)≥15.5 mm;r_(s)≥0.5 mm.

In an embodiment 18 of the process 1 according to the invention theprocess 1 is designed according to its embodiment 17, wherein shaping inprocess step III) is performed in such a way that the followingconditions are fulfilled: d_(n)≥15.5 mm; preferably d_(n)≥15.6 mm; morepreferably d_(n)≥15.7 mm; even more preferably d_(n)≥15.8 mm; mostpreferably d_(n)≥15.9 mm.

In an embodiment 19 of the process 1 according to the invention theprocess 1 is designed according to its embodiment 17 or 18, whereinshaping in process step III) is performed in such a way that thefollowing conditions are fulfilled: r_(s)≥0.5 mm; preferably r_(s)≥0.55mm; more preferably r_(s)≥0.6 mm; even more preferably r_(s)≥0.7 mm;most preferably r_(s)≥0.8 mm.

In an embodiment 20 of the process 1 according to the invention theprocess 1 is designed according to anyone its embodiments 4 to 13,wherein the glass container is a vial with an interior volume of 22.5 to150 ml and wherein shaping in process step III) is performed in such away that the following conditions are fulfilled: d_(n)≥16.5 mm;r_(s)≥0.5 mm.

In an embodiment 21 of the process 1 according to the invention theprocess 1 is designed according to its embodiment 20, wherein shaping inprocess step III) is performed in such a way that the followingconditions are fulfilled: d_(n)≥16.5 mm; preferably d_(n)≥16.6 mm; morepreferably d_(n)≥16.7 mm; even more preferably d_(n)≥16.8 mm; mostpreferably d_(n)≥16.9 mm.

In an embodiment 22 of the process 1 according to the invention theprocess 1 is designed according to its embodiment 20 or 21, whereinshaping in process step III) is performed in such a way that thefollowing conditions are fulfilled: r_(s)≥0.5 mm; preferably r_(s)≥0.55mm; more preferably r_(s)≥0.6 mm; even more preferably r_(s)≥0.7 mm;most preferably r_(s)≥0.8 mm.

In an embodiment 23 of the process 1 according to the invention, theprocess 1 is designed according to any of its embodiments 1 to 22,wherein the glass of the glass tube that is provided in process step I)is of a type selected from the group consisting of a borosilicate glass,an aluminosilicate glass, soda lime glass and fused silica.

In an embodiment 24 of the process 1 according to the invention, theprocess 1 is designed according to any of its embodiments 1 to 23,wherein the glass container is not thermally tempered.

In an embodiment 25 of the process 1 according to the invention, theprocess 1 is designed according to any of its embodiments 1 to 24,wherein the glass of glass container at least in the neck region ischaracterized by a substantially homogeneous distribution of sodiumacross the thickness n_(b) of the glass.

In an embodiment 26 of the process 1 according to the invention, theprocess 1 is designed according to any of its embodiments 1 to 25,wherein the glass of glass container at least in the neck region ischaracterized by a substantially homogeneous distribution of potassiumacross the thickness n_(b) of the glass.

In an embodiment 27 of the process 1 according to the invention, theprocess 1 is designed according to any of its embodiments 1 to 27,wherein the glass of glass container at least in the neck region ischaracterized by a compressive stress (CS) in the outer surface regionin the neck region which is lower than 500 MPa, preferably lower than300 MPa, even more preferably lower than 170 MPa, even more preferablylower than 80 MPa, even more preferably lower than 30 MPa and mostpreferably lower than 15 MPa. The compressive stress can, for example,be measured with a polarimeter which is appropriate for vial geometries.

A contribution to solving at least one of the objects according to theinvention is made by an embodiment 1 of a glass container 2 obtainableby the process 1 of the invention according to any of its embodiments 1to 27. In a preferred embodiment of the glass container 2, this glasscontainer 2 shows the technical features of the glass container 1 of theinvention and the technical features of each glass container containedin the plurality 1 of glass containers of the invention according to anyof its embodiments, respectively.

A contribution to solving at least one of the objects according to theinvention is made by an embodiment 1 of a process 2 comprising asprocess steps providing a glass container 1 according to any of itspreferred embodiments, a plurality 1 of glass containers according toany of its preferred embodiments, or the glass container 2 according toany of its preferred embodiments; inserting a pharmaceutical compositioninto the interior volume V_(i) of the glass container; and closing theglass container.

The closing in the process step c) preferably comprises contacting theglass container with a closure, preferably a lid, preferably covering anopening of the glass container with the closure, and joining the closureto the hollow body. The joining preferably comprises creating a form-fitof the glass container, preferably the flange of the glass container,with the closure. The form-fit is preferably created via a crimpingstep. The process 2 is preferably a process for packaging thepharmaceutical composition.

A contribution to solving at least one of the objects according to theinvention is made by an embodiment 1 of a closed glass containerobtainable by the process 2 of the invention according to any of itsembodiments.

A contribution to solving at least one of the objects according to theinvention is made by an embodiment 1 of a process 3 comprising asprocess steps providing a glass container 1 according to any of itspreferred embodiments, a plurality 1 of glass containers according toany of its preferred embodiments, or the glass container 2 according toany of its preferred embodiments; and administering the pharmaceuticalcomposition to a patient.

A contribution to solving at least one of the objects according to theinvention is made by an embodiment 1 of a use 1 of the glass container 1according to any of its preferred embodiments, of a plurality 1 of glasscontainers according to any of its preferred embodiments or of the glasscontainer 2 according to any of its preferred embodiments for packaginga pharmaceutical composition. The packaging preferably comprisesinserting the pharmaceutical composition into the interior volume andclosing the glass container.

Glass Container

The glass container according to the invention or the glass containercontained in the plurality of glass containers according to theinvention may have any size or shape which the skilled person deemsappropriate in the context of the invention. Preferably, the top regionof the glass container comprises an opening, which allows for insertinga pharmaceutical composition into the interior volume of the glasscontainer. The glass container comprises as container parts a glass tubewith a first end and a further end and a glass bottom that closes theglass tube at the further end. Preferably, the glass container is of aone-piece design that is prepared by providing a glass tube and byshaping one end thereof (i. e. the end that will be the opening of theglass container) so as to obtain a top region, a junction region, a neckregion and a shoulder region followed by a step of shaping the furtherend of the glass tube so as to obtain a closed glass bottom. A preferredglass container is a pharmaceutical glass container, more preferably oneselected from the group consisting of a vial, an ampoule or acombination thereof, wherein a vial is particularly preferred.

For the use in this document, the interior volume V_(i) represents thefull volume of the interior of the glass container. This volume may bedetermined by filling the interior of the glass container with water upto the brim and measuring the volume of the amount of water which theinterior can take up to the brim. Hence, the interior volume as usedherein is not a nominal volume as it is often referred to in thetechnical field of pharmacy. This nominal volume may for example be lessthan the interior volume by a factor of about 0.5.

Glass

The glass of the container may be any type of glass and may consist ofany material or combination of materials which the skilled person deemssuitable in the context of the invention. Preferably, the glass issuitable for pharmaceutical packaging. Particularly preferable, theglass is of type I, more preferably type I b, in accordance with thedefinitions of glass types in section 3.2.1 of the EuropeanPharmacopoeia, 7^(th) edition from 2011. Additionally, or alternativelypreferable to the preceding, the glass is selected from the groupconsisting of a borosilicate glass, an aluminosilicate glass, soda limeglass and fused silica; or a combination of at least two thereof. Forthe use in this document, an aluminosilicate glass is a glass which hasa content of Al₂O₃ of more than 8 wt.-%, preferably more than 9 wt.-%,particularly preferable in a range from 9 to 20 wt.-%, in each casebased on the total weight of the glass. A preferred aluminosilicateglass has a content of B₂O₃ of less than 8 wt.-%, preferably at maximum7 wt.-%, particularly preferably in a range from 0 to 7 wt.-%, in eachcase based on the total weight of the glass. For the use in thisdocument, a borosilicate glass is a glass which has a content of B₂O₃ ofat least 1 wt.-%, preferably at least 2 wt.-%, more preferably at least3 wt.-%, more preferably at least 4 wt.-%, even more preferably at least5 wt.-%, particularly preferable in a range from 5 to 15 wt.-%, in eachcase based on the total weight of the glass. A preferred borosilicateglass has a content of Al₂O₃ of less than 7.5 wt.-%, preferably lessthan 6.5 wt.-%, particularly preferably in a range from 0 to 5.5 wt.-%,in each case based on the total weight of the glass. In a furtheraspect, the borosilicate glass has a content of Al₂O₃ in a range from 3to 7.5 wt.-%, preferably in a range from 4 to 6 wt.-%, in each casebased on the total weight of the glass.

A glass which is further preferred according to the invention isessentially free from B. Therein, the wording “essentially free from B”refers to glasses which are free from B which has been added to theglass composition by purpose. This means that B may still be present asan impurity, but preferably at a proportion of not more than 0.1 wt.-%,more preferably not more than 0.05 wt.-%, in each case based on theweight of the glass.

Outer Contour of the Junction Region

An important element of the glass container 1 according to theinvention, of the glass containers contained in the plurality 1 of glasscontainers according to the invention and of the glass container 2according to the invention is the mechanical strength of the neck regiontowards a load that is laterally applied to the neck region in the neckside compression test as described in section “Measurement Methods”,wherein this mechanical strength can, for example, be realized by a veryspecial outer contour c_(outer) of the glass container in the junctionregion, i. e. in the transition area between the top region and the neckregion, this outer contour c_(outer) being characterized by a certainminimum value of curvature in that region.

For the determination of that minimum value of the angle of curvature inthat region the glass container is placed on a plane horizontalsubstrate with the outer surface of the body region on it. Within anygiven cross-section of the glass container that is located in a planebeing centrically located in the glass container and comprising thelongitudinal axis L_(tube) of the glass tube, f(x) defines the verticaldistance [mm] between the substrate and the outer surface of the glasscontainer at a given position x (f(x) thus describes the outer contourc_(outer) of the glass container) and l(x) defines the thickness of theglass [mm] at a given position x, wherein the thickness of the glassl(x) is measured in a direction perpendicular to longitudinal axisL_(tube). From f(x) the local curvature k(x) can be determined asfollows: k(x)=|f″(x)/[1+f′(x)2]^(3/2)|.

The outer contour c_(outer) of the glass containers according to thepresent invention is now characterized in that in the interval betweenx=P₁ and x=P₂ for any concave curvature in this interval the minimalvalue for [l(x)/l_(b)]³/k(x) is at least 0.35 mm, preferably at least0.5 mm, more preferably at least 0.7 mm, even more preferably at least0.9 mm, even more preferably at least 1.1 mm, even more preferably atleast 1.3 mm, even more preferably at least 1.5 mm, even more preferablyat least 1.7 mm, even more preferably at least 2.0 mm and mostpreferably at least 2.5 mm, wherein P₂ defines the x-position at whichf(x) is ½×d_(b)−¼×d_(t)−¼×d_(n) and P₁ is P₂−d_(t)/2+d_(n)/2.

Pharmaceutical Composition

In the context of the invention, every pharmaceutical composition whichthe skilled person deems suitable comes into consideration. Apharmaceutical composition is a composition comprising at least oneactive ingredient. A preferred active ingredient is a vaccine. Thepharmaceutical composition may be fluid or solid or both, wherein afluid composition is particularly preferred herein. A preferred solidcomposition is granular such as a powder, a multitude of tablets or amultitude of capsules. A further preferred pharmaceutical composition isa parenterialium, i.e. a composition which is intended to beadministered via the parenteral route, which may be any route which isnot enteral. Parenteral administration can be performed by injection,e.g. using a needle (usually a hypodermic needle) and a syringe, or bythe insertion of an indwelling catheter.

According to a first preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity equal to or larger than 1 ml up to maximal 5 ml,preferably a vial with a size designation “2R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 9.5 to 16.5 mm, more preferably inthe range from 11 to 15 mm and even more preferably in the range from12.5 to 13.5 mm; d_(n) is in the range from 8 to 13 mm, more preferablyin the range from 9 to 12 mm and even more preferably in the range from10 to 11 mm; d_(b) is in the range from 14 to 18 mm, more preferably inthe range from 15 to 17 mm and even more preferably in the range from15.5 to 16.5 mm; l_(b) is in the range from 0.4 to 2 mm, more preferablyin the range from 0.8 to 1.3 mm and even more preferably in the rangefrom 0.9 to 1.15 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35 mm,preferably ≥1.5 mm, more preferably ≥1.8 mm and even more preferably≥2.1 mm; 2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and morepreferably ≥2.0 mm; h_(c) is in the range from 32 to 38 mm, morepreferably in the range from 33.5 to 36.5 mm and even more preferably inthe range from 34.5 to 35.5 mm; h_(b) is in the range from 12 to 32 mm,more preferably in the range from 17 to 27 mm and even more preferablyin the range from 21 to 23 mm; h_(t-n) is in the range from 6 to 10 mm,more preferably in the range from 7 to 9 mm and even more preferably inthe range from 7.5 to 8.5 mm.

According to a second preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 4 ml up to maximal 8 ml, preferably avial with a size designation “4R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 9.5 to 16.5 mm, more preferably inthe range from 11 to 15 mm and even more preferably in the range from12.5 to 13.5 mm; d_(n) is in the range from 8 to 13 mm, more preferablyin the range from 9 to 12 mm and even more preferably in the range from10 to 11 mm; d_(b) is in the range from 14 to 18 mm, more preferably inthe range from 15 to 17 mm and even more preferably in the range from15.5 to 16.5 mm; l_(b) is in the range from 0.4 to 2 mm, more preferablyin the range from 0.8 to 1.3 mm and even more preferably in the rangefrom 0.9 to 1.15 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35 mm,preferably ≥1.5 mm, more preferably ≥1.8 mm and even more preferably≥2.1 mm; 2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and morepreferably ≥2.0 mm; h_(c) is in the range from 42 to 48 mm, morepreferably in the range from 43.5 to 46.5 mm and even more preferably inthe range from 44.5 to 45.5 mm; h_(b) is in the range from 22 to 42 mm,more preferably in the range from 27 to 37 mm and even more preferablyin the range from 31 to 33 mm; h_(t-n) is in the range from 6 to 10 mm,more preferably in the range from 7 to 9 mm and even more preferably inthe range from 7.5 to 8.5 mm.

According to a third preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 8 ml up to maximal 10.75 ml, preferablya vial with a size designation “6R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 14 to 19 mm, morepreferably in the range from 15 to 18 mm and even more preferably in therange from 16 to 17 mm; d_(b) is in the range from 19.5 to 24.5 mm, morepreferably in the range from 20.5 to 23.5 mm and even more preferably inthe range from 21.5 to 22.5 mm; l_(b) is in the range from 0.4 to 2 mm,more preferably in the range from 0.8 to 1.3 mm and even more preferablyin the range from 0.9 to 1.15 mm; minimum value of[l(x)/l_(b)]³/k(x)≥0.35 mm, preferably ≥1.5 mm, more preferably ≥1.8 mmand even more preferably ≥2.1 mm; 2×[l_(n)/l_(b)]×r_(s)≥0.9 mm,preferably ≥1.5 mm and more preferably ≥2.0 mm; h_(c) is in the rangefrom 37 to 43 mm, more preferably in the range from 38.5 to 41.5 mm andeven more preferably in the range from 39.5 to 40.5 mm; h_(b) is in therange from 16 to 36 mm, more preferably in the range from 21 to 31 mmand even more preferably in the range from 25 to 27 mm; h_(t-n) is inthe range from 6.5 to 10.5 mm, more preferably in the range from 7.5 to9.5 mm and even more preferably in the range from 8 to 9 mm.

According to a fourth preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 10.75 ml up to maximal 12.5 ml,preferably a vial with a size designation “8R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 14 to 19 mm, morepreferably in the range from 15 to 18 mm and even more preferably in therange from 16 to 17 mm; d_(b) is in the range from 19.5 to 24.5 mm, morepreferably in the range from 20.5 to 23.5 mm and even more preferably inthe range from 21.5 to 22.5 mm; l_(b) is in the range from 0.4 to 2 mm,more preferably in the range from 0.8 to 1.3 mm and even more preferablyin the range from 0.9 to 1.15 mm; minimum value of[l(x)/l_(b)]³/k(x)≥0.35 mm, preferably ≥1.5 mm, more preferably ≥1.8 mmand even more preferably ≥2.1 mm; 2×[l_(n)/l_(b)]×r_(s)≥0.9 mm,preferably ≥1.5 mm and more preferably ≥2.0 mm; h_(c) is in the rangefrom 42 to 47 mm, more preferably in the range from 43.5 to 46.5 mm andeven more preferably in the range from 44.5 to 45.5 mm; h_(b) is in therange from 21 to 41 mm, more preferably in the range from 26 to 36 mmand even more preferably in the range from 30 to 32 mm; h_(t-n) is inthe range from 6.5 to 10.5 mm, more preferably in the range from 7.5 to9.5 mm and even more preferably in the range from 8 to 9 mm.

According to a fifth preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 12.5 ml up to maximal 16.25 ml,preferably a vial with a size designation “10R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 14 to 19 mm, morepreferably in the range from 15 to 18 mm and even more preferably in therange from 16 to 17 mm; d_(b) is in the range from 21 to 27 mm, morepreferably in the range from 22 to 26 mm and even more preferably in therange from 23.5 to 24.5 mm; l_(b) is in the range from 0.4 to 2 mm, morepreferably in the range from 0.8 to 1.3 mm and even more preferably inthe range from 0.9 to 1.15 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35mm, preferably ≥1.5 mm, more preferably ≥1.8 mm and even more preferably≥2.1 mm; 2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and morepreferably ≥2.0 mm; h_(c) is in the range from 42 to 47 mm, morepreferably in the range from 43.5 to 46.5 mm and even more preferably inthe range from 44.5 to 45.5 mm; h_(b) is in the range from 20 to 40 mm,more preferably in the range from 25 to 35 mm and even more preferablyin the range from 29 to 31 mm; h_(t-n) is in the range from 7 to 11 mm,more preferably in the range from 8 to 10 mm and even more preferably inthe range from 8.5 to 9.5 mm.

According to a sixth preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 16.25 ml up to maximal 22.5 ml,preferably a vial with a size designation “15R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 14 to 19 mm, morepreferably in the range from 15 to 18 mm and even more preferably in therange from 16 to 17 mm; d_(b) is in the range from 21 to 27 mm, morepreferably in the range from 22 to 26 mm and even more preferably in therange from 23.5 to 24.5 mm; l_(b) is in the range from 0.4 to 2 mm, morepreferably in the range from 0.8 to 1.3 mm and even more preferably inthe range from 0.9 to 1.15 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35mm, preferably ≥1.5 mm, more preferably ≥1.8 mm and even more preferably≥2.1 mm; 2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and morepreferably ≥2.0 mm; h_(c) is in the range from 56 to 64 mm, morepreferably in the range from 58 to 62 mm and even more preferably in therange from 59.5 to 60.5 mm; h_(b) is in the range from 35 to 55 mm, morepreferably in the range from 40 to 50 mm and even more preferably in therange from 44 to 46 mm; h_(t-n) is in the range from 7 to 11 mm, morepreferably in the range from 8 to 10 mm and even more preferably in therange from 8.5 to 9.5 mm.

According to a seventh preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 22.5 ml up to maximal 29.25 ml,preferably a vial with a size designation “20R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 15 to 20 mm, morepreferably in the range from 16 to 19 mm and even more preferably in therange from 17 to 18 mm; d_(b) is in the range from 27 to 33 mm, morepreferably in the range from 28 to 32 mm and even more preferably in therange from 29.5 to 30.5 mm; l_(b) is in the range from 0.5 to 2.5 mm,preferably in the range from 0.7 to 2 mm, even more preferably in therange from 0.9 to 1.6 mm and most preferably in the range from 1.15 to1.25 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35 mm, preferably ≥1.5mm, more preferably ≥1.8 mm and even more preferably ≥2.1 mm;2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and more preferably≥2.0 mm; h_(c) is in the range from 51 to 59 mm, more preferably in therange from 53 to 57 mm and even more preferably in the range from 54.5to 55.5 mm; h_(b) is in the range from 15 to 55 mm, more preferably inthe range from 25 to 45 mm, even more preferably in the range from 30 to40 mm and most preferably in the range from 34 to 36 mm; h_(t-n) is inthe range from 7 to 13 mm, more preferably in the range from 8.5 to 11.5mm and even more preferably in the range from 9.25 to 10.75 mm.

According to an eighth preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 29.25 ml up to maximal 35 ml,preferably a vial with a size designation “25R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 15 to 20 mm, morepreferably in the range from 16 to 19 mm and even more preferably in therange from 17 to 18 mm; d_(b) is in the range from 27 to 33 mm, morepreferably in the range from 28 to 32 mm and even more preferably in therange from 29.5 to 30.5 mm; l_(b) is in the range from 0.5 to 2.5 mm,preferably in the range from 0.7 to 2 mm, even more preferably in therange from 0.9 to 1.6 mm and most preferably in the range from 1.15 to1.25 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35 mm, preferably ≥1.5mm, more preferably ≥1.8 mm and even more preferably ≥2.1 mm;2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and more preferably≥2.0 mm; h_(c) is in the range from 61 to 69 mm, more preferably in therange from 63 to 67 mm and even more preferably in the range from 64.5to 65.5 mm, h_(b) is in the range from 25 to 65 mm, more preferably inthe range from 35 to 55 mm, even more preferably in the range from 40 to50 mm and most preferably in the range from 44 to 46 mm; h_(t-n) is inthe range from 7 to 13 mm, more preferably in the range from 8.5 to 11.5mm and even more preferably in the range from 9.25 to 10.75 mm.

According to a ninth preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 35 ml up to maximal 49.75 ml,preferably a vial with a size designation “30R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 15 to 20 mm, morepreferably in the range from 16 to 19 mm and even more preferably in therange from 17 to 18 mm; d_(b) is in the range from 27 to 33 mm, morepreferably in the range from 28 to 32 mm and even more preferably in therange from 29.5 to 30.5 mm; l_(b) is in the range from 0.5 to 2.5 mm,preferably in the range from 0.7 to 2 mm, even more preferably in therange from 0.9 to 1.6 mm and most preferably in the range from 1.15 to1.25 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35 mm, preferably ≥1.5mm, more preferably ≥1.8 mm and even more preferably ≥2.1 mm;2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and more preferably≥2.0 mm; h_(c) is in the range from 71 to 79 mm, more preferably in therange from 73 to 77 mm and even more preferably in the range from 74.5to 75.5 mm; h_(b) is in the range from 35 to 75 mm, more preferably inthe range from 45 to 65 mm, even more preferably in the range from 50 to60 mm and most preferably in the range from 54 to 56 mm; h_(t-n) is inthe range from 7 to 13 mm, more preferably in the range from 8.5 to 11.5mm and even more preferably in the range from 9.25 to 10.75 mm.

According to a tenth preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 49.75 ml up to maximal 92.5 ml,preferably a vial with a size designation “50R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 15 to 20 mm, morepreferably in the range from 16 to 19 mm and even more preferably in therange from 17 to 18 mm; d_(b) is in the range from 37 to 43 mm, morepreferably in the range from 38 to 42 mm and even more preferably in therange from 39.5 to 40.5 mm; l_(b) is in the range from 0.5 to 2.5 mm,preferably in the range from 0.7 to 2 mm, even more preferably in therange from 0.9 to 1.6 mm and most preferably in the range from 1.15 to1.25 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35 mm, preferably ≥1.5mm, more preferably ≥1.8 mm and even more preferably ≥2.1 mm;2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and more preferably≥2.0 mm; h_(c) is in the range from 69 to 77 mm, more preferably in therange from 71 to 75 mm and even more preferably in the range from 72.5to 73.5 mm; h_(b) is in the range from 29 to 69 mm, more preferably inthe range from 39 to 59 mm, even more preferably in the range from 44 to54 mm and most preferably in the range from 48 to 50 mm; h_(t-n) is inthe range from 7 to 13 mm, more preferably in the range from 8.5 to 11.5mm and even more preferably in the range from 9.25 to 10.75 mm.

According to an eleventh preferred embodiment of the glass container 1according to the present invention the glass container is a vial with anoverflow capacity of larger than 92.5 ml up to maximal 150 ml,preferably a vial with a size designation “100R” according to DIN EN ISO8362-1:2016-06, wherein it is furthermore preferred that at least one,preferably all of the following conditions i) to x) is/are fulfilled:r_(s) is in the range from 0.5 to 1.0 mm, more preferably in the rangefrom 0.6 to 0.95 mm and even more preferably in the range from 0.75 to0.9 mm; d_(t) is in the range from 17.5 to 23.0 mm, more preferably inthe range from 18.5 to 22.0 mm and even more preferably in the rangefrom 19.5 to 20.5 mm; d_(n) is in the range from 15 to 20 mm, morepreferably in the range from 16 to 19 mm and even more preferably in therange from 17 to 18 mm; d_(b) is in the range from 43 to 51 mm, morepreferably in the range from 45 to 49 mm and even more preferably in therange from 46.5 to 47.5 mm; l_(b) is in the range from 0.5 to 2.5 mm,preferably in the range from 0.7 to 2 mm, even more preferably in therange from 0.9 to 1.6 mm and most preferably in the range from 1.15 to1.25 mm; minimum value of [l(x)/l_(b)]³/k(x)≥0.35 mm, preferably ≥1.5mm, more preferably ≥1.8 mm and even more preferably ≥2.1 mm;2×[l_(n)/l_(b)]×r_(s)≥0.9 mm, preferably ≥1.5 mm and more preferably≥2.0 mm; h_(c) is in the range from 96 to 103 mm, more preferably in therange from 98 to 101 mm and even more preferably in the range from 99.5to 100.5 mm; h_(b) is in the range from 55 to 95 mm, more preferably inthe range from 65 to 85 mm, even more preferably in the range from 70 to80 mm and most preferably in the range from 74 to 76 mm; h_(t-n) is inthe range from 7 to 13 mm, more preferably in the range from 8.5 to 11.5mm and even more preferably in the range from 9.25 to 10.75 mm.

Measurement Methods

The following measurement methods are to be used in the context of theinvention. Unless otherwise specified, the measurements have to becarried out at an ambient temperature of 23° C., an ambient air pressureof 100 kPa (0.986 atm) and a relative atmospheric humidity of 50%.

Determination of the Local Curvature K(X) and the Local Glass ThicknessL(X)

The local curvature k(x) of the outer contour c_(outer) defined by thefunction f(x) as well as the local thickness l(x) of the glass in thejunction region, i. e. in transition area between the top region and theneck region, can be determined in a non-destructive manner using aprofile projector. This approach is particularly suitable for glasscontainers that have been chemically and/or thermally tempered and thattherefore cannot be easily sliced in half without the glass cracking orbursting. For determining the local curvature k(x) in a non-destructivemanner the outer contour of the glass containers is visualized using aMitutoyo PJ-3000 profile projector. The profile projector has a 10×magnification and is operated with transmitted light illumination. Thevials are placed in Hallbrite® BHB (a butyloctyl salicylate obtainablefrom the Hallstar Company, Chicago, USA), which is filled into a glassbowl. Hallbrite® BHB is used to visualize the outer contour of the vial.It is ensured that the cross-section of the glass container that isinspected in the profile projector corresponds to the plane that iscentrically located in the glass container and that comprises thelongitudinal axis L_(tube) of the glass container, i. e. the axis thatgoes perpendicular through the centre of the bottom (see FIGS. 5A and5B).

To improve the measuring accuracy, the outer contour c_(outer) as wellas the local thickness l(x) of the glass in the transition area betweenthe top region and in the neck region can also be determined from aphysical cross-sectional cut parallel along to the longitudinal axis ofthe container (it is again ensured that the cross-section of the glasscontainer corresponds to the plane that is centrically located in theglass container and that comprises the longitudinal axis as shown inFIGS. 5A and 5B). For preparation without breakage, the container may beembedded into transparent 2-component epoxy resin, for example STRUERSGmbH, EpoFix Resin, or other suitable materials. After curing of theepoxy resin, a cross-sectional cut parallel along to the container axiscan be achieved by machine-supported sawing, grinding and polishing.Geometrical features of the container can then be determined (measured)by means of non-distorting image capturing and geometrical analysissoftware tools.

The thickness of the glass l(x) measured in a direction perpendicular tolongitudinal axis L_(tube) can be determined from these images by meansof an electronic ruler with any appropriate image analysis softwaretool.

The relevant outer contour c_(outer) of the outer surface of the glasscontainers in the transition region between the top region and thebottom region can be extracted and numerically approximated from theimages obtained by means of the two approaches described above. For theextraction of the relevant contour of the outer surface, the imagesundergo the image processing steps implemented in Python[https://www.python.org/] based on the image processing library OpenCV[https://opencv.org/].

First, the images are denoised using a median filter. The denoisedimages are then processed with an edge detection algorithm based on aSobel filter, in which the contours are identified by thresholding thegradient image. For the calculation of slopes and curvatures, theextracted contours are numerically approximated by a univariate splineof order 5. The radii of curvature R(x) are then given by the formula:

$R = \frac{\left( {1 + \left( \frac{dx}{dy} \right)^{2}} \right)^{\frac{3}{2}}}{\frac{d^{2}x}{dy^{2}}}$${{wherein}{R(x)}} = \frac{1}{k(x)}$

Determination of R_(s)

For the determination of the outer radius r_(s) of the substantiallycircular arc-shaped area at the end of the junction region that mergesinto the neck region in images obtained by means of the two approachesdescribed above point A on the outer surface of the junction region isdetermined at which the slope β of the tangent reaches its maximum value(see FIG. 6 ). In case of a liner area in which the slope β of thetangent reaches a maximum value, A is defined at the point which isnearest to the neck region. In a second step, line b is defined as theextension of the essentially non-curved outer surface of the neckregion. Now the largest possible circle is formed, which is adjacent atpoint A and coincides at gradient (=bevel circle) and which only touchesline b (at point B), but does not cross it (see again FIG. 6 ). Theradius of that circle corresponds to r_(s).

Wall Thicknesses and Diameters

The wall thickness of the glass container at a given position as well asthe inner or outer diameter of the glass container at a given positionare determined in accordance with DIN ISO 8362-1.

Neck Squeeze Test

The mechanical resistance of the vial neck section against diametralcompression is determined by means of a diametral load strength testingadapted from DIN EN ISO 8113 (“Glass containers—Resistance to verticalload—Test methods”), where a compressive force is applied in diametral(radial) direction at two opposing positions of the vial neck outersurface geometry. The compressive force is increased at a constant loadrate of 2000 N/min until breakage of the container using a universaltesting machine (breakage can be detected as a sudden drop in theforce-time diagram F(t)). The diametral load is applied by two opposing,uniaxial concave steel surfaces, between which the neck section of thevial is placed parallel to the axis. One of the concave surfaces isconstructed to be self-adjusting to be able to compensate geometricalirregularities. The radius of the concavity of the two steel surfaces is25% larger than the radius of the outer diameter of the neck section, sothat the load is applied along two opposing lines. The width of theconcave steel surfaces is chosen to be slightly shorter than the heightof the vial neck section.

Side Compression Test

The mechanical resistance of the vial body section against diametralcompression is determined by means of a diametral load strength testingadapted from DIN EN ISO 8113 (“Glass containers—Resistance to verticalload—Test methods”), where a compressive force is applied in diametral(radial) direction at two opposing positions of the vial body outersurface geometry. The compressive force is increased at a constant loadrate of 1500 N/min until breakage of the container using a universaltesting machine (breakage can again be detected as a sudden drop in theforce-time diagram F(t)). The diametral load is applied by two opposing,uniaxial concave steel surfaces, between which the body section of thevial is placed parallel to the axis. One of the concave surfaces isconstructed to be self-adjusting to be able to compensate geometricalirregularities. The radius of the concavity of the two steel surfaces is25% larger than the radius of the outer diameter of the body section, sothat the load is applied along two opposing lines. The width of theconcave steel surfaces is chosen to be larger than the height of thevial body section.

EXAMPLES

A glass tube having an outer diameter of 16 mm and a wall thicknessl_(b) of 1 mm made of borosilicate glass is loaded into the head of arotary machine. While rotating around its major axis the glass tube isheated at the bottom end to its softening point with flames and theheated end is shaped to form the top region, the junction region, theneck region and the shoulder region. For the formation of the desiredshape of these regions in the rotary machine the glass tube is broughtin an upward position as indicated in FIG. 8 . By using support rollershaving the desired outer shape to ensure that the required maximumcurvature and the required values for d_(t)−d_(n), d_(n) and l_(n) arealways realized in the transition area between the top region and theneck region the outer contour c_(outer) in the top region, the junctionregion, the neck region and the shoulder region is formed. Furtherinformation for forming these regions of a glass vial can also be foundathttps://www.schott.com/pharmaceutical_packaging/german/about_us/videos.html.

In a further step, the glass tube, while rotating around its major axis,is heated at a position above the first end that has been previouslyshaped to its softening point with flames and the heated glass is pulledalong its major axis for stretching and creating a container closure.

By means of the above described process and by varying the shape of thesupport rollers, glass containers with a size designation “10R”according to DIN EN ISO 8362-1:2016-06 which differ with respect to theshape of the outer contour c_(outer) in the junction region, i. e. inthe transition area between the top region and the neck region has beengenerated.

For each shape at least 50 glass containers have been prepared in therotary machine. The shape of one of the outer contours c_(outer) in thetransition area between the top region and the neck region correspondsto the shape of that area in glass containers known in the prior art(Comparative Example 1).

TABLE 1 Glass d_(t) d_(n) d_(b) 2 × [l_(n)/l_(b)] × r_(s)[l(x)/l_(b)]³/k(x)¹⁾ container [mm] [mm] [mm] [mm] [mm] Comparative 2015.4 24 0.84 0.32 Example 1 Example 1 20 15.7 24 2.17 1.83

The minimum value for [l(x)/l_(b)]³/k(x) in the interval between pointsP₁ and P₂ is given in the table above.

Evaluation

From the above described glass containers the resistance to withstandloads in the neck squeeze test as well as in the side compression testhave been determined. For each shape of the outer contour c_(outer) inthe transition area between the top region and the neck region 50 vialshave been tested. The loads that have been determined correspond to thepressures at which 10% of the vials break. The results are shown inTABLE 2, wherein the corresponding load values for side compression testare standardised to the values that have been determined for thereference vial of the Comparative Example.

TABLE 2 resistance to load in the resistance to load in the neck squeezetest side compression test Glass container [N] [%] Comparative 1007 100Example 1 Example 1 1676 116

As can be seen from the results shown in TABLE 2, by adjusting the outercontour c_(outer) in the transition area between the top region and theneck region as well as by adjusting the resistance neck squeeze test theresistance to loads in the side compression test can be significantlyincreased.

BRIEF DESCRIPTION OF THE FIGURES

Unless otherwise specified in the description or the particular figure:

FIG. 1 shows the set-up of a side compression test known from the priorart;

FIG. 2 shows in a cross-sectional view the different regions of a glasscontainer 100 according to the invention;

FIG. 3 shows in an enlarged cross-sectional view the top region 104, thejunction region 105, the neck region 106 and the shoulder region 107 ofa glass container 100 according to the invention;

FIG. 4A shows in an enlarged cross-sectional view the determination ofthe outer contour c_(outer) of the top region 104, the junction region105, the neck region 106 and the shoulder region 107 of a glasscontainer 100 according to the invention;

FIG. 4B shows the course of the function f(x) within the range from P₁to P₂ that describes the outer contour c_(outer) in the transition areabetween the top region and the neck region;

FIG. 5A shows in a side view the localization of plane 111 that is usedto determine the local curvature of function f(x) as well as the glassthickness l(x) within the range from P₁ to P₂;

FIG. 5B shows in a top view the localization of plane 111 that is usedto determine the local curvature of function f(x) as well as the glassthickness l(x) within the range from P₁ to P₂;

FIG. 6 shows the determination of r_(s);

FIG. 7 is further a cross-sectional view of a glass container 100according to the invention showing a shoulder angle α;

FIG. 8 illustrates the process 1 according to the invention for thepreparation of a glass container;

FIG. 9 shows a flow chart of process 2 according to the invention forpackaging a pharmaceutical composition;

FIG. 10 shows the set-up of the neck squeeze test;

FIG. 11A is a schematic side view of the neck squeeze test;

FIG. 11B is a schematic front view of the neck squeeze test.

DETAILED DESCRIPTION

FIG. 1 shows the set-up of a side compression test known from the priorart. As can be seen, the glass container 100 with a glass bottom 109 isplaced in a horizontal position sandwiched between two steel plates117,118 by means of which a compressive force is applied in diametral(radial) direction at two opposing positions of the vial body outersurface geometry. The compressive force is increased at a constant loadrate of 1500 N/min until breakage of the container using a universaltesting machine. The diametral load is applied by two opposing, uniaxialconcave steel surfaces 117, 118, between which the body region 109 ofthe vial 100 is placed parallel to the axis L_(tube). One of the concavesurfaces 117 is constructed to be self-adjusting to be able tocompensate geometrical irregularities. The radius of the concavity ofthe two steel surfaces 117,118 is 25% larger than the radius of theouter diameter d_(b) of the body region, so that the load is appliedalong two opposing lines. The width of the concave steel surfaces ischosen to be larger than the height of the vial body region 108. As canalso be seen in FIG. 1 , neither the top region 104 nor the junctionregion 105 or the neck region 106 come into contact with the clampingjaws 117,118 as d_(t) (the diameter of the top region 104) and d_(n)(the diameter of the neck region 106) are smaller than d_(b) (thediameter of the body region 108).

FIG. 2 shows in a cross-sectional view the different regions of a glasscontainer 100 according to the invention. The glass container 100comprises as container parts a glass tube 101 with a first end 102 and afurther end 103 and a glass bottom 109 that closes the glass tube 101 atthe further end 103. The glass tube 101 is characterized by alongitudinal axis L_(tube) and comprises, in a direction from the top tothe bottom, a top region 104 that is located at the first end 102 of theglass tube 101, wherein the outer diameter of the top region is d_(t), ajunction region 105 that follows the top region 104, a neck region 106that follows the junction region 105, wherein the outer diameter of theneck region is d_(n) with d_(n)<d_(t), a shoulder region 107 thatfollows the neck region 106; and a body region 108 that follows theshoulder region 107 and that extends to the further end 103 of the glasstube 101, wherein the thickness of the glass in the body region is l_(b)and wherein the outer diameter of the body region is d_(b) withd_(b)>d_(t). Junction region 105 corresponds to the transition areabetween the top region 104 and the neck region 106. l_(n) is the minimumthickness of the glass in the neck region 106. The neck region 106 isdefined by a substantially linear and almost horizontal course of thefunction f(x) defining the outer contour c_(outer) of the glasscontainer 100 (see FIG. 4B). The beginning and the ending of the neckregion 106 are thus defined by those points at which the course of thisfunction f(x) is no longer linear and horizontal. The beginning and theending of the neck region 106 are indicated as points x₁ and x₂ and FIG.4B.

FIG. 3 shows in an enlarged cross-sectional view the top region 104, thejunction region 105, the neck region 106 and the shoulder region 107 ofa glass container 100 according to the invention (the body region 108that follows the shoulder region 109 is not shown in that figure). InFIG. 3 the junction region 105 has an outer surface that at the end atwhich the junction region 105 merges with the neck region 106 issubstantially circular arc-shaped, the substantially circular arc-shapedarea having an outer radius r_(s).

FIG. 4A shows in an enlarged cross-sectional view the determination ofthe outer contour c_(outer) of the top region 104, the junction region105, the neck region 106 and the shoulder region 107 of a glasscontainer 100 according to the invention based on images of the glasscontainer 100 as they have been obtained with the methods describedherein in the section “Test methods”. These images are positioned insuch a way that glass container 100 is placed on a plane horizontalsubstrate 110 with the outer surface of the body region 108 on it. k(x)and l(x) are then determined between points P₁ and P₂ as also describedherein in the section “Test methods”. s corresponds to (d_(t)−d_(n))/2,s/2 corresponds to (d_(t)−d_(n))/4 which means that P₂ is the x-positionat which f(x) is(d_(b)−d_(t))/2+s/2=(d_(b)−d_(t))/2+(d_(t)−d_(n))/4=½×d_(b)−¼×d_(t)−¼×d_(n).P₁ is then the x-position P₂−s=P₂−d_(t)/2+d_(n)/2. FIG. 4B shows thecourse of the function f(x) describing the outer contour c_(outer)between points P₁ and P₂. Points x₁ and x₂ indicate the beginning andthe ending of the neck region 106.

FIGS. 5A and 5B show in a side view and in a top view the localizationof plane 111 in the glass container 100 that is used to determine thatis used to determine the local curvature of function f(x) as well as theglass thickness l(x) within the range from P₁ to P₂ by means of theapproach that is shown in FIGS. 4A and 4B. Plane 111 corresponds to theplane that is centrically located in the glass container and thatcomprises the longitudinal axis L_(tube) (see FIG. 2 ) of the glasscontainer (indicated by the dashed line in FIG. 5A), i. e. the axis thatgoes perpendicular through the centre of the bottom 109 (see FIG. 5B).

FIG. 6 shows the determination of r_(s). For the determination of theouter radius r_(s) of the substantially circular arc-shaped area at theend of the junction region 105 that merges into the neck region 106 inimages of planes 111 obtained by means of the two approaches describedherein in the section “Test methods” point A on the outer surface of thejunction region 105 is determined at which the slope β of the tangent112 reaches its maximum value. In case of a linear section in which theslope β of the tangent 112 reaches a maximum value, A is defined at thepoint which is nearest to the neck region 106. In s second step, line b113 is defined as the extension of the essentially non-curved outersurface of the neck region 106. Now the largest possible circle 114 isformed, which is adjacent at point A and coincides at gradient (=bevelcircle) and which only touches line b 113 (at point B), but does notcross it (see again FIG. 6 ). The radius of that circle corresponds tor_(s).

FIG. 7 shows a cross sectional view of a further glass container 100according to the invention having a height h_(c). h_(c) corresponds tothe length of the body region 108 and h_(t-n) to the total length of thetop region 104, the junction region 105 and the neck region 106. Theglass container 100 comprises a shoulder region 107 that connects thebody region 108 with the neck region 106, wherein shoulder region 107 ischaracterized by a shoulder angle α.

FIG. 8 shows a process for the formation of a top region 104, a junctionregion 105, a neck region 106 and a shoulder region 107 in a container100 according to the present invention. A glass tube 101 having an outerdiameter d_(b) of 16 mm and a glass thickness (wall thickness) l_(b) of1 mm made of borosilicate glass is loaded into the head of a rotarymachine. While rotating around its major axis the glass tube 101 isheated at the bottom end to its softening point with flames 116 and theheated end is shaped to form the top region 104, the junction region105, the neck region 106 and the shoulder region 107. For the formationof the desired shape of these regions in the rotary machine the glasstube 101 is brought in an upward position as indicated in FIG. 8 . Byusing molding rollers 115 having the desired outer shape to ensure thatthe required maximum curvature is always realized in the transition areabetween the top region 104 and the neck region 106 the outer contourc_(outer) in the top region 104, the junction region 105, the neckregion 106 and the shoulder region 107 is formed.

FIG. 9 shows a flow chart of a process 200 according to the inventionfor packaging a pharmaceutical composition. In a process step a) 201, aglass container 100 according to the invention is provided. In a processstep b) 202, a pharmaceutical composition is filled into the interiorvolume V_(i) of the glass container 100, and in a process step c) 203the opening 112 of the glass container 100 is closed, thereby obtaininga closed glass container 121.

FIG. 10 shows the test to determine the mechanical resistance of thevial neck region 106 against diametral compression. The resistance isdetermined by means of a diametral load strength testing adapted fromDIN EN ISO 8113 (“Glass containers—Resistance to vertical load—Testmethods”), where a compressive force is applied in diametral (radial)direction at two opposing positions of the outer surface of the neckregion 106. The compressive force is increased at a constant load rateof 2000 N/min until breakage of the vial 100 using a universal testingmachine (breakage can be detected as a sudden drop in the force-timediagram F(t)). The diametral load is applied by two opposing, uniaxialconcave steel plates 119,120 between which the neck region 106 of thevial 100 is placed parallel to the axis L_(tube). One of the concavesteel plates 119 is constructed to be self-adjusting to be able tocompensate geometrical irregularities. The radius of the concavity ofthe two steel surfaces is 25% larger than the radius of the outerdiameter d_(n) of the neck region 106, so that the load is applied alongtwo opposing lines. The width of the concave steel surfaces is chosen tobe slightly shorter than the height of the vial neck region 104.

FIGS. 11A and 11B show a schematic side view and a schematic front viewof the neck squeeze test.

LIST OF REFERENCE NUMERALS

-   100 glass container according to the invention-   101 glass tube-   102 first end of the glass tube 101-   103 further end of the glass tube 101-   104 top region-   105 junction region-   106 neck region-   107 shoulder region-   108 body region-   109 glass bottom-   110 planar and horizontal substrate-   111 cross-sectional plane in the middle of the glass container 100-   112 tangent with maximum slope β-   113 extension of the essentially non-curved outer surface of the    neck region 105 (line b)-   114 largest possible circle-   115 molding roller-   116 heating element, preferably a flame-   117 self-adjusting steel plate-   118 rigid steel plate-   119 self-adjusting steel plate-   120 rigid steel plate-   200 process according to the invention for packaging a    pharmaceutical composition-   201 process step a)-   202 process step b)-   203 process step c)

What is claimed is:
 1. A glass container, comprising: a glass tubehaving, in order along a longitudinal axis (L_(tube)), a first end, atop region, a junction region, a neck region, a shoulder region, a bodyregion, and a second end, wherein the top region has an outer diameter(d_(t)), the neck region has an outer diameter (d_(n)) with d_(n)<d_(t),the body region has an outer diameter (d_(b)) with d_(b)>d_(t), and theglass tube in the body region has a thickness (l_(b)); and a glassbottom closing the glass tube at the second end, an area comprising thejunction region and the neck region has an outer contour with a localcurvature configured so that a test load applied at the neck region isat least 65% more than a comparative glass container without the localcurvature and a side compression load applied at the body region is atleast 16% more than the comparative glass container without the localcurvature.
 2. The glass container of claim 1, wherein the test loadapplied at the neck region is at least 1100 N.
 3. The glass container ofclaim 1, wherein the test load applied at the neck region is at least1800 N.
 4. The glass container of claim 1, wherein the test load appliedat the neck region is at least 3000 N.
 5. The glass container of claim1, wherein the glass container is a vial having an interior volume of 1to 8 ml, and d_(n)≥9.7 mm, and r_(s)≥0.5 mm.
 6. The glass container ofclaim 5, wherein the vial has a size designation “2R” or “4R” accordingto DIN EN ISO 8362-1:2016-06.
 7. The glass container of claim 1, whereinthe glass container is a vial with an interior volume of 8.5 to 22 ml,d_(n)≥15.5 mm, and r_(s)≥0.5 mm.
 8. The glass container of claim 7,wherein the vial has a size designation “6R”, “8R” or “10R” according toDIN EN ISO 8362-1:2016-06.
 9. The glass container of claim 1, whereinthe glass container is a vial with an interior volume of 22.5 to 150 ml,d_(n)≥16.5 mm, and r_(s)≥0.5 mm.
 10. The glass container of claim 9,wherein the vial has a size designation “20R”, “25R”, “30R”, “50R” or“100R” according to DIN EN ISO 8362-1:2016-06.
 11. The glass containerof claim 1, wherein, when an outer surface of the body region is placedon a plane horizontal substrate, within a cross-section of the glasscontainer that is located in a plane centrically located in the glasscontainer and comprising the longitudinal axis L_(tube), f(x) defines adistance between the plane horizontal substrate and the outer surface ofthe glass tube at a position x and l(x) defines a thickness of the glasstube at the position x, wherein the thickness of the glass tube l(x) ismeasured for the position x in a direction perpendicular to thelongitudinal axis L_(tube), wherein whereink(x)=|f″(x)/[1+f′(x)²]^(3/2)| defines an absolute value of a curvatureof f(x) at a given position x; and wherein the local curvature in aninterval between x=P₁ and x=P₂ for a concave curvature has a minimumvalue for [l(x)/l_(b)]³/k(x) that is at least 0.35 mm, wherein P₂defines the x-position at which f(x) is ½×d_(b)−¼×d_(t)−¼×d_(n) and P₁is P₂−d_(t)/2+d_(n)/2.
 12. The glass container of claim 11, wherein thejunction region has another outer surface where the junction regionmerges into the neck region that is substantially circular arc-shaped,the substantially circular arc-shaped area having an outer radius r_(s),wherein the glass tube has a minimum thickness l_(n) in the neck region,and wherein 2×[l_(n)/l_(b)]×r_(s)≥0.9 mm.
 13. The glass container ofclaim 12, wherein l_(n)/l_(b)≥1.4.
 14. The glass container of claim 12,wherein l_(n)×r_(s)/l_(b)≥0.7 mm.
 15. The glass container of claim 1,further comprising a pharmaceutical composition in an interior volume ofthe glass tube and a closure closing the glass tube at the first end.16. The glass container of claim 1, wherein the shoulder region has ashoulder angle in a range from 10° to 70°.
 17. A plurality of glasscontainers, comprising: each glass container having a glass tube with afirst end and a second end and having a glass bottom closing the glasstube at the second end, wherein the glass tube has an outer surface, alongitudinal axis L_(tube) and has, in a direction from the first end tothe second end, a top region, a junction region, a neck region, ashoulder region, and a body region, wherein the top region is at thefirst end and has an outer diameter (d_(t)), the neck region has anouter diameter (d_(n)) with d_(n)<d_(t), the body region extends to thesecond end and has an outer diameter (d_(b)) with d_(b)>d_(t), and theglass tube in the body region has a thickness (l_(b)), and wherein anarea comprising the junction region and the neck region has an outercontour with a local curvature configured so that 50% of the glasscontainers withstand a neck squeeze test load of at least 1100 N. 18.The plurality of glass containers of claim 17, wherein the localcurvature is configured so that at least 75% of the glass containers inthe plurality of glass containers fulfil a condition comprising: when anouter surface of the body region is placed on a plane horizontalsubstrate, within a cross-section of the glass container that is locatedin a plane centrically located in the glass container and comprising thelongitudinal axis L_(tube), f(x) defines a distance between the planehorizontal substrate and the outer surface of the glass tube at aposition x and l(x) defines a thickness of the glass tube at theposition x, wherein the thickness of the glass tube l(x) is measured forthe position x in a direction perpendicular to the longitudinal axisL_(tube), wherein k(x)=|f″(x)/[1+f′(x)²]^(3/2)| defines an absolutevalue of a curvature of f(x) at a given position x; and wherein, in aninterval between x=P₁ and x=P₂ for a concave curvature in the intervalbetween x=P₁ and x=P₂, a minimum value for [l(x)/l_(b)]³/k(x) is atleast 0.35 mm, wherein P₂ defines the x-position at which f(x) is½×d_(b)−¼×d_(t)−¼×d_(n) and P₁ is P₂−d_(t)/2+d_(n)/2.
 19. The pluralityof glass containers of claim 18, wherein the local curvature isconfigured so that at least 75% of the glass containers in the pluralityof glass containers fulfil a condition comprising: the junction regionhas another outer surface where the junction region merges into the neckregion that is substantially circular arc-shaped, the substantiallycircular arc-shaped area having an outer radius r_(s), wherein the glasstube has a minimum thickness l_(n) in the neck region, and wherein2×[l_(n)/l_(b)]×r_(s)≥0.9 mm.
 20. The plurality of glass containers ofclaim 17, wherein each of the glass containers in the plurality of glasscontainers further comprise a pharmaceutical composition in an interiorvolume of the glass tube and a closure closing the glass tube at thefirst end.